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A Safety and Pharmacokinetics Study of IDP-122 Lotion in Pediatric Participants With Plaque Psoriasis
Sponsor: Bausch Health Americas, Inc.
Summary
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.
Official title: A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
Key Details
Gender
All
Age Range
6 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2019-10-22
Completion Date
2026-06
Last Updated
2025-08-27
Healthy Volunteers
No
Conditions
Interventions
IDP-122 Lotion
Topical
Locations (9)
Bausch Site 11
Fountain Valley, California, United States
Bausch Site 2
Thousand Oaks, California, United States
Bausch Site 07
Doral, Florida, United States
Bausch Site 3
Miami, Florida, United States
Bausch Site 06
Miami, Florida, United States
Bausch Site 05
Spartanburg, South Carolina, United States
Bausch Site 1
Spokane, Washington, United States
Bausch Site 12
Santo Domingo, Dominican Republic
Bausch Site 4
Panama City, Panama